CN112292162A - Method and apparatus for manufacturing medical instrument - Google Patents
Method and apparatus for manufacturing medical instrument Download PDFInfo
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- CN112292162A CN112292162A CN201980041547.7A CN201980041547A CN112292162A CN 112292162 A CN112292162 A CN 112292162A CN 201980041547 A CN201980041547 A CN 201980041547A CN 112292162 A CN112292162 A CN 112292162A
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- 238000000034 method Methods 0.000 title claims abstract description 19
- 238000007789 sealing Methods 0.000 claims abstract description 102
- 230000002093 peripheral effect Effects 0.000 claims abstract description 45
- 239000007791 liquid phase Substances 0.000 claims description 105
- 239000012071 phase Substances 0.000 claims description 100
- 239000007788 liquid Substances 0.000 claims description 56
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- 238000005192 partition Methods 0.000 claims description 7
- 239000008280 blood Substances 0.000 description 116
- 210000004369 blood Anatomy 0.000 description 116
- 238000003466 welding Methods 0.000 description 19
- 238000000502 dialysis Methods 0.000 description 12
- 239000002504 physiological saline solution Substances 0.000 description 12
- 239000000047 product Substances 0.000 description 10
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- 238000001514 detection method Methods 0.000 description 6
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/247—Positive displacement blood pumps
- A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
- A61M60/268—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
- B23P—METAL-WORKING NOT OTHERWISE PROVIDED FOR; COMBINED OPERATIONS; UNIVERSAL MACHINE TOOLS
- B23P19/00—Machines for simply fitting together or separating metal parts or objects, or metal and non-metal parts, whether or not involving some deformation; Tools or devices therefor so far as not provided for in other classes
- B23P19/04—Machines for simply fitting together or separating metal parts or objects, or metal and non-metal parts, whether or not involving some deformation; Tools or devices therefor so far as not provided for in other classes for assembling or disassembling parts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3639—Blood pressure control, pressure transducers specially adapted therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3639—Blood pressure control, pressure transducers specially adapted therefor
- A61M1/3641—Pressure isolators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/247—Positive displacement blood pumps
- A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
- A61M60/268—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
- A61M60/279—Peristaltic pumps, e.g. roller pumps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/845—Constructional details other than related to driving of extracorporeal blood pumps
- A61M60/851—Valves
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01L—MEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE
- G01L19/00—Details of, or accessories for, apparatus for measuring steady or quasi-steady pressure of a fluent medium insofar as such details or accessories are not special to particular types of pressure gauges
- G01L19/06—Means for preventing overload or deleterious influence of the measured medium on the measuring device or vice versa
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01L—MEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE
- G01L7/00—Measuring the steady or quasi-steady pressure of a fluid or a fluent solid material by mechanical or fluid pressure-sensitive elements
- G01L7/02—Measuring the steady or quasi-steady pressure of a fluid or a fluent solid material by mechanical or fluid pressure-sensitive elements in the form of elastically-deformable gauges
- G01L7/08—Measuring the steady or quasi-steady pressure of a fluid or a fluent solid material by mechanical or fluid pressure-sensitive elements in the form of elastically-deformable gauges of the flexible-diaphragm type
- G01L7/082—Measuring the steady or quasi-steady pressure of a fluid or a fluent solid material by mechanical or fluid pressure-sensitive elements in the form of elastically-deformable gauges of the flexible-diaphragm type construction or mounting of diaphragms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
- A61M2207/10—Device therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/104—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body
- A61M60/109—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/30—Medical purposes thereof other than the enhancement of the cardiac output
- A61M60/36—Medical purposes thereof other than the enhancement of the cardiac output for specific blood treatment; for specific therapy
- A61M60/37—Haemodialysis, haemofiltration or diafiltration
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01L—MEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE
- G01L19/00—Details of, or accessories for, apparatus for measuring steady or quasi-steady pressure of a fluent medium insofar as such details or accessories are not special to particular types of pressure gauges
- G01L19/14—Housings
- G01L19/142—Multiple part housings
- G01L19/143—Two part housings
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Cardiology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Anesthesiology (AREA)
- Vascular Medicine (AREA)
- Mechanical Engineering (AREA)
- Physics & Mathematics (AREA)
- General Physics & Mathematics (AREA)
- Urology & Nephrology (AREA)
- External Artificial Organs (AREA)
Abstract
The present invention relates to a method for manufacturing a medical instrument, the medical instrument including: a housing in which a1 st housing part and a2 nd housing part are formed in an anastomotic manner, with a receiving space inside the housing; an elastic film attached to the housing, the elastic film defining a1 st receiving space covered by the 1 st housing part and a2 nd receiving space covered by the 2 nd housing part; a fixing portion formed at a peripheral edge portion of each of the 1 st and 2 nd casing portions, for fixing the 1 st and 2 nd casing portions in a fitted state; a holding surface formed on the peripheral edge of each of the 1 st and 2 nd casing parts, for holding the peripheral edge of the elastic film; and a sealing portion formed inside the fixing portion in the peripheral edge portion of the 1 st or 2 nd casing portion and sealing the elastic film sandwiched by the sandwiching surfaces over the entire periphery, wherein when the fixing of the fixing portion and the sealing of the sealing portion are performed and the 1 st and 2 nd casing portions are assembled, the inside of a gap formed between the fixing portion and the sealing portion is decompressed or heated.
Description
Technical Field
The present invention relates to a method and an apparatus for manufacturing a medical device having an elastic film that divides a1 st receiving space covered by a1 st housing part and a2 nd receiving space covered by a2 nd housing part.
Background
In general, in dialysis treatment, a blood circuit is used in which blood of a collected patient is extracorporeally circulated and returned to the body again, and the blood circuit is mainly composed of, for example, an arterial blood circuit and a venous blood circuit, and the arterial blood circuit and the venous blood circuit are connectable to, for example, a dialyzer (blood purifier) having a hollow fiber membrane. An artery side puncture needle and a vein side puncture needle are attached to the respective distal ends of the artery side blood circuit and the vein side blood circuit, and the respective artery side puncture needle and vein side puncture needle are punctured in a patient to perform extracorporeal circulation of blood for dialysis treatment.
In order to detect the pressure of blood extracorporeally circulated in a blood circuit, as disclosed in patent document 1, for example, there is proposed a pressure detector including: a housing connectable to a blood circuit; and a diaphragm (membrane member) which is attached to the inside of the housing, which partitions a liquid phase portion in which blood in the blood circuit can be filled and a gas phase portion in which air can be filled, and which is displaceable in accordance with the pressure of the blood filled in the liquid phase portion, and which detects the pressure of the gas phase portion by means of a pressure detection sensor, thereby detecting the pressure of the blood. According to this conventional pressure detector, since the liquid phase portion and the gas phase portion are divided by the membrane member, the pressure of blood in the blood circuit can be detected with good accuracy while avoiding contact between the blood and the air in the gas phase portion.
Documents of the prior art
Patent document
Patent document 1: JP patent publication No. 2017-504389
Disclosure of Invention
Problems to be solved by the invention
However, in the conventional pressure detector described above, when the peripheral portions of the 1 st case and the 2 nd case are fixed by ultrasonic welding or the like while fitting the half cases (the 1 st case and the 2 nd case), the diaphragm is sealed at the entire periphery by the seal portion formed on the 1 st case or the 2 nd case, so that a sealed space is formed between the seal portion and the fixing portion (welded portion), and there is a risk that the pressure in the sealed space excessively rises during welding.
However, if the pressure in the sealed space rises excessively, for example, in the case of high-pressure steam sterilization after production, in the case of annealing or in the case of a high temperature environment, the pressure in the sealed space further rises, the diaphragm is displaced in the radial direction, and the sealing performance is lowered, which may cause defective products or defective products. In particular, when the 1 st housing and the 2 nd housing are fixed, pressure rise in the sealed space is significant and the diaphragms may be displaced in the radial direction in the case of press-fitting involving ultrasonic fusion or the like.
Such a problem occurs not only in the pressure detector having the diaphragm but also in other medical instruments configured to divide the receiving spaces in the 1 st and 2 nd housings by the elastic membrane. The present applicant has conducted extensive studies to improve quality and reliability of such a medical device by suppressing an excessive increase in pressure in a gap formed between the sealing portion and the fixing portion.
The present invention has been made in view of the above circumstances, and an object of the present invention is to provide a method and an apparatus for manufacturing a medical device, in which an increase in excessive pressure in a gap formed between a sealing portion and a fixing portion is suppressed, thereby improving quality and reliability.
Means for solving the problems
The invention described in claim 1 relates to a method for manufacturing a medical device, the medical device including: a housing in which a1 st housing part and a2 nd housing part are formed in an anastomotic manner, with a receiving space inside the housing; an elastic film attached to the housing, the elastic film defining a1 st receiving space covered by the 1 st housing part and a2 nd receiving space covered by the 2 nd housing part; a fixing portion formed at a peripheral edge portion of each of the 1 st and 2 nd casing portions, for fixing the 1 st and 2 nd casing portions in a fitted state; a holding surface formed on the peripheral edge of each of the 1 st and 2 nd casing parts, for holding the peripheral edge of the elastic film; and a sealing portion formed inside the fixing portion in the peripheral edge portion of the 1 st or 2 nd casing portion and sealing the elastic film sandwiched by the sandwiching surfaces over the entire periphery, wherein when the fixing of the fixing portion and the sealing of the sealing portion are performed and the 1 st and 2 nd casing portions are assembled, the inside of a gap formed between the fixing portion and the sealing portion is decompressed or heated.
The invention described in claim 2 relates to the method for manufacturing a medical device described in claim 1, wherein the first case portion and the second case portion are fixed to a jig in a state where the first case portion and the second case portion are fitted to each other while the elastic film is built in, the fixing of the fixing portions and the sealing of the sealing portions are performed, the first case portion and the second case portion are assembled, the periphery of at least the first case portion and the second case portion fixed by the jig is sealed, and the sealed space is decompressed or heated.
The invention described in claim 3 relates to the method for manufacturing a medical device described in claim 2, wherein the sealed space is pressurized or cooled after the sealed space is depressurized or heated.
The invention described in claim 4 relates to the method for manufacturing the medical device described in any one of claims 1 to 3, wherein the medical device is configured by a pressure detector, the housing is connectable to a flow path of a liquid, the 1 st receiving space is configured by a liquid phase portion in which the liquid in the flow path can be filled, the 2 nd receiving space is configured by a gas phase portion in which a gas can be filled, and the elastic membrane is configured by a membrane member that partitions the liquid phase portion and the gas phase portion, is displaced in accordance with a pressure of the liquid filled in the liquid phase portion, and detects a pressure of the liquid in the flow path by detecting a pressure of the gas phase portion.
The invention described in claim 5 relates to a manufacturing apparatus of a medical instrument including:
a housing in which a1 st housing part and a2 nd housing part are formed in an anastomotic manner, with a receiving space inside the housing;
an elastic film attached to the housing, the elastic film defining a1 st receiving space covered by the 1 st housing part and a2 nd receiving space covered by the 2 nd housing part;
a fixing portion formed at a peripheral edge portion of each of the 1 st and 2 nd casing portions, for fixing the 1 st and 2 nd casing portions in a fitted state;
a holding surface formed on the peripheral edge of each of the 1 st and 2 nd casing parts, for holding the peripheral edge of the elastic film;
a sealing portion formed inside the fixing portion in a peripheral edge portion of the 1 st or 2 nd casing portion, the sealing portion sealing the elastic film sandwiched by the sandwiching surfaces at an entire periphery;
the manufacturing apparatus for a medical device is characterized by comprising a decompression unit for decompressing an inside of a gap formed between the fixing unit and the sealing unit when the fixing unit is fixed and the sealing unit is sealed, and the heating unit for heating the inside of the gap when the 1 st and 2 nd casing units are assembled.
The invention described in claim 6 relates to the apparatus for manufacturing a medical device described in claim 5, the apparatus comprising:
a jig for fixing the 1 st and 2 nd casing parts in a state of being fitted to each other while incorporating the elastic film therein;
a sealing part for sealing the periphery of at least the 1 st housing part and the 2 nd housing part fixed by the clamp;
and the pressure reducing portion or the heating portion reduces or heats the pressure in the sealed space of the sealing portion when the fixing portion is fixed and the sealing portion is sealed to assemble the 1 st housing portion and the 2 nd housing portion.
The invention described in claim 7 relates to the apparatus for manufacturing a medical device described in claim 6, wherein the closed space is pressurized or cooled after the pressure is reduced or heated.
The invention according to claim 8 relates to the manufacturing apparatus of the medical device according to any one of claims 5 to 7, wherein the medical device is configured by a pressure detector, the housing is connectable to a flow path of a liquid, the 1 st receiving space is configured as a liquid phase portion in which the liquid in the flow path can be filled, the 2 nd receiving space is configured as a gas phase portion in which a gas can be filled, and the elastic membrane is configured by a membrane member that partitions the liquid phase portion and the gas phase portion, is displaceable in accordance with a pressure of the liquid filled in the liquid phase portion, and detects a pressure of the liquid in the flow path by detecting a pressure of the gas phase portion.
ADVANTAGEOUS EFFECTS OF INVENTION
According to the invention described in claims 1 and 5, when the first housing part 1 and the second housing part 2 are assembled by fixing the fixing part and sealing the sealing part, the inside of the space formed between the fixing part and the sealing part is decompressed or heated, so that it is possible to improve the quality and reliability by suppressing an excessive increase in pressure in the space formed between the sealing part and the fixing part.
According to the invention described in claims 2 and 6, since the 1 st and 2 nd casing parts are fixed to the jig in a state of fitting while the elastic film is built in, the fixing of the fixing parts and the sealing of the sealing parts are performed, the 1 st and 2 nd casing parts are assembled, the periphery of at least the 1 st and 2 nd casing parts fixed by the jig is sealed, and the sealed space is decompressed or heated, the decompression or heating inside the void can be performed with good efficiency.
According to the inventions of claims 3 and 7, since the sealed space is pressurized or cooled after the sealed space is depressurized or heated, the product can be taken out from the time of returning to a stable environment, and the quality can be improved.
According to the invention described in claims 4 and 8, since the medical device is constituted by the pressure detector in which the housing is connectable to the flow path of the liquid, the 1 st receiving space constitutes a liquid phase portion in which the liquid in the flow path can be filled, the 2 nd receiving space constitutes a gas phase portion in which the gas can be filled, and the elastic membrane is constituted by the membrane member which partitions the liquid phase portion and the gas phase portion and is displaceable in accordance with the pressure of the liquid filled in the liquid phase portion, and the pressure of the liquid in the flow path is detected by detecting the pressure in the gas phase portion, it is possible to suppress an excessive increase in pressure in the gap formed between the sealing portion and the fixing portion, and to improve the quality and reliability of the pressure detector.
Drawings
Fig. 1 is a schematic view of a dialysis apparatus (blood purification apparatus) as a pressure detector of a medical device according to embodiment 1 of the present invention;
FIG. 2 is a plan view showing the pressure detector;
FIG. 3 is a front view showing the pressure detector;
fig. 4 is a sectional view taken along the line IV-IV in fig. 2 (a state where the membrane member is displaced to the liquid phase portion side);
fig. 5 is a sectional view taken along the line IV-IV in fig. 2 (a state where the membrane member is displaced to the gas phase portion side);
FIG. 6 is a cross-sectional view taken along line VI-VI in FIG. 2;
FIG. 7 is a three-dimensional view showing a1 st housing part of the pressure detector;
FIG. 8 is a three-dimensional view showing a2 nd case portion of the pressure detector;
FIG. 9 is a plan view and a front view showing a membrane member of the pressure detector;
fig. 10 is an enlarged cross-sectional view showing a state before fixing of a fixing portion of the pressure detector and sealing of a sealing portion are performed;
fig. 11 is an enlarged cross-sectional view showing a state where fixing of a fixing portion of the pressure detector and sealing of a sealing portion are performed;
FIG. 12 is a schematic view showing a manufacturing apparatus of the pressure detector;
FIG. 13 is a schematic view showing a manufacturing apparatus of the pressure detector;
FIG. 14 is a flowchart showing a method for manufacturing the pressure detector (in the case of pressure reduction);
FIG. 15 is a flowchart showing a method of manufacturing the pressure detector (in the case of heating);
fig. 16 is a plan view showing a diaphragm pump (of a type in which a single port is formed in a gas phase portion casing) as a medical instrument according to another embodiment of the present invention;
FIG. 17 is a sectional view taken along line Xc-Xc in FIG. 16;
fig. 18 is a plan view showing a diaphragm pump (of a type in which 5 ports are formed in a gas phase portion casing) as a medical instrument according to another embodiment of the present invention;
fig. 19 is a sectional view taken along line Xd-Xd in fig. 18.
Detailed Description
Embodiments of the present invention will be specifically described below with reference to the accompanying drawings.
The blood purification apparatus used in embodiment 1 is constituted by a dialysis apparatus for performing dialysis treatment, and as shown in fig. 1, the blood purification apparatus is mainly constituted by a portion including a blood circuit constituted by an arterial side blood circuit 1 and a venous side blood circuit 2; a dialyzer (blood purifier) 3 interposed between the arterial blood circuit 1 and the venous blood circuit 2 for purifying blood flowing through the blood circuits; a blood pump 4; an air trap chamber 5, the air trap chamber 5 being provided in the vein-side blood circuit 2; a dialysis device main body 6 for supplying a dialysis liquid to the dialyzer 3 and discharging a drain from the dialyzer 3, the dialysis device main body 6 being provided with a filter; a physiological saline solution supply line L3 (replacement solution supply line) through which a physiological saline solution as a replacement solution can be supplied to the blood circuit via the physiological saline solution supply line L3; a receiving part 7, wherein the receiving part 7 receives the physiological saline solution as the replacement solution.
An artery side puncture needle a is connected to the tip of the artery side blood circuit 1 via a connector, and a squeeze type blood pump 4 may be provided in the middle of the artery side blood circuit 1. On the other hand, the vein-side puncture needle b may be connected to the tip of the vein-side blood circuit 2 via a connector, and the air trap chamber 5 may be connected to the middle of the vein-side blood circuit 2. Also, the air trap chamber 5 can trap air bubbles in the liquid, and a filter net (not shown in the figure) is provided, for example, to trap thrombus or the like at the time of returning blood. In the present specification, the side of the puncture needle for performing a blood removal process (blood collection process) on blood is referred to as "artery side", the side of the puncture needle for performing a blood return process on blood is referred to as "vein side", and the "artery side" and the "vein side" are defined such that a blood vessel to be punctured is not defined by either an artery or a vein.
The blood pump 4 is constituted by a squeeze pump provided in the arterial blood circuit 1, and is capable of performing normal rotation driving and reverse rotation driving and causing a liquid in the blood circuit to flow in a driving direction. That is, a tube to be squeezed, which has a larger diameter than the other flexible tube constituting the artery-side blood circuit 1 and is made of a material softer than the other flexible tube constituting the artery-side blood circuit 1, is connected to the artery-side blood circuit 1, and a roller for squeezing the tube to be squeezed in the liquid feeding direction is provided in the blood pump 4. When the blood pump 4 is driven in this manner, the roller rotates to squeeze the tube to be squeezed (a part of the blood circuit), and the liquid inside can be made to flow in the driving direction (the rotation direction of the roller).
However, if the blood pump 4 is driven in the normal direction (left-hand direction in the drawing) in a state where the arterial needle a and the venous needle b are inserted into the patient, the blood of the patient reaches the dialyzer 3 through the arterial blood circuit 1, and then the dialyzer 3 performs a blood purification process, and the blood is returned to the body of the patient through the venous blood circuit 2 while being defoamed by the air trap chamber 5. That is, the blood of the patient is purified by the dialyzer 3 while being extracorporeally circulated from the tip of the arterial blood circuit 1 to the tip of the venous blood circuit 2 of the blood circuit. Further, if the blood pump 4 is driven in reverse (rightward in the figure), blood in the blood circuit (between the distal end of the arterial blood circuit 1 and the position where the blood pump 4 is disposed) can be returned to the patient.
The dialyzer 3 has a blood introduction port 3a, a blood discharge port 3b, a dialysate introduction port 3c, and a dialysate discharge port 3d formed in its outer casing, and the arterial blood circuit 1 is connected to the blood introduction port 3a and the venous blood circuit 2 is connected to the blood discharge port 3 b. The dialysate introduction port 3c and the dialysate discharge port 3d are connected to a dialysate introduction line L1 and a dialysate discharge line L2, respectively, which extend from the dialysis apparatus body 6.
A plurality of hollow wires are housed in the dialyzer 3, and the inside of the hollow wires forms a blood flow path, and a dialysate flow path is formed between the outer peripheral surface of the hollow wire and the inner peripheral surface of the housing. The structure is as follows: the hollow fiber is formed with a plurality of fine holes penetrating the outer and inner peripheral surfaces of the hollow fiber, and a hollow fiber membrane is formed through which impurities in blood and the like permeate into the dialysate in the dialysate flow path.
On the other hand, in the dialysis apparatus main body 6, a liquid feeding portion such as the double pump 9 is provided across the dialysate introduction line L1 and the dialysate discharge line L2, and a water removing pump for removing water from the blood of the patient flowing through the dialyzer 3 is provided in a bypass line bypassing the liquid feeding portion. One end of the dialysate introduction line L1 is connected to the dialyzer 3 (dialysate introduction port 3c), and the other end of the dialysate introduction line L1 is connected to a dialysate supply device (not shown in the figure) that prepares dialysate of a predetermined concentration. One end of the dialysate discharge line L2 is connected to the dialyzer 3 (dialysate leading-out port 3d), and the other end of the dialysate discharge line L2 is connected to a drain (not shown), and the dialysate supplied from the dialysate supply device reaches the dialysate flow path of the dialyzer 3 through the dialysate introduction line L1, and then is supplied to the drain through the dialysate discharge line L2.
Further, an overflow line is extended from the upper portion of the air trap chamber 5, and a clamping portion such as a solenoid valve is provided in the middle. Further, by opening the clamping portion such as the solenoid valve, the liquid (priming liquid or the like) flowing from the blood circuit can be overflowed through the overflow line.
The physiological saline solution supply line L3 (replacement solution supply line) is constituted by a flow path (e.g., a flexible tube or the like) one end of which is connected between the position where the blood pump 4 of the arterial blood circuit 1 is disposed and the tip of the arterial blood circuit 1 via a T-shaped tube or the like, and which is capable of supplying a physiological saline solution (replacement solution) for replacing blood in the blood circuit to the arterial blood circuit 1. A receiving portion 7 (so-called "saline bag") for receiving a predetermined amount of saline is connected to the other end of the saline supply line L3, and an air trap chamber 8 is connected to the middle of the saline supply line L3.
In addition, the physiological saline supply line L3 of the present embodiment is provided with a clamp 9 (e.g., an electromagnetic valve). The holder 9 is provided so as to be openable and closable with respect to the physiological saline supply line L3, and is capable of closing and opening the flow path, and by opening and closing the holder 9, the closed state in which the flow path of the physiological saline supply line L3 is closed and the flow state in which the physiological saline (replacement fluid) flows can be arbitrarily switched. Instead of the holding section 9, a common mechanism such as forceps that can close and open the flow path of the physiological saline supply line L3 by a manual mechanism may be provided.
Here, the blood circuit used in the present embodiment is connected to a pressure sensor 10 as a medical instrument. The pressure sensor 10 is configured as follows: which is connected to a position between the dialyzer 3 and the air trap chamber 5 in the vein-side blood circuit 2, the pressure of blood flowing through the vein-side blood circuit 2 (blood circuit) can be detected. Specifically, the pressure sensor 10 includes a housing C connectable to a liquid channel (in the present embodiment, the vein-side blood circuit 2 (blood circuit)) as shown in fig. 2 to 6; a membrane member M attached to the inside of the housing C, the membrane member M defining a liquid phase portion S1 and a gas phase portion S2, the liquid phase portion S1 being filled with the liquid in the channel (in the present embodiment, the blood in the vein-side blood circuit 2 (blood circuit)), the gas phase portion S2 being filled with air, the membrane member M being displaced in accordance with the pressure of the liquid (blood) filled in the liquid phase portion S1, and the pressure of the liquid in the channel (vein-side blood circuit 2) being detectable by detecting the pressure of the gas phase portion S2 with the pressure detection sensor P.
The case C is formed of a hollow molded member which can be molded with a predetermined resin material or the like, and is formed by combining a liquid phase portion case Ca constituting the liquid phase portion S1 and a gas phase portion case Cb constituting the gas phase portion S2. Specifically, the case C forms a liquid phase portion case Ca (1 st case portion) and a gas phase portion case Cb (2 nd case portion) in a fitting manner, and has a receiving space therein. An inlet port C1 and an outlet port C2 are integrally formed in the liquid phase portion casing Ca, and the inlet port C1 and the outlet port C2 can communicate with the flow path of the liquid and can communicate with the liquid phase portion S1, and a connection port C3 is integrally formed in the gas phase portion casing Cb, and the connection port C3 can be connected to one end of a pipe portion K described later and can communicate with the gas phase portion S2. In addition, in the inflow port C1 and the outflow port C2, the inflow and outflow of the liquid may be reversed (i.e., a structure in which the liquid flows out through the inflow port C1 and the liquid flows in through the outflow port C2).
Further, an annular sandwiching surface M1 (see fig. 7) is formed on the outer peripheral edge of the liquid phase portion casing Ca, and an annular sandwiching surface M2 (see fig. 8) is formed on the outer peripheral edge of the gas phase portion casing Cb, so that when the liquid phase portion casing Ca and the gas phase portion casing Cb are assembled by fitting them together, the outer peripheral portion Ma of the film member M is sandwiched between the sandwiching surface M1 and the sandwiching surface M2, whereby the film member M can be attached while sealing the film member M. The space formed in the housing C is divided into a liquid phase section S1 and a gas phase section S2 by the membrane member M.
The membrane member M is a diaphragm attached to the inside of the case C, and is formed of a flexible material that can be displaced or deformed in accordance with a pressure change in the liquid phase portion S1 or the gas phase portion S2. The membrane member M of the present embodiment is formed of an elastic member attached to the housing C, and divides the liquid phase portion S1 (1 st receiving space) covered with the liquid phase portion housing Ca (1 st housing portion) and the gas phase portion S2 (2 nd receiving space) covered with the gas phase portion housing Cb (2 nd housing portion), and the peripheral edge portion Ma is formed so as to protrude laterally as shown in fig. 9 and is configured to be sandwiched by the sandwiching surfaces M1 and M2. When the pressure (hydraulic pressure) of the liquid in the liquid phase portion S1 is low, as shown in fig. 4, the membrane member M is displaced toward the liquid phase portion S1 side to increase the capacity of the gas phase portion S2, and when the pressure (hydraulic pressure) of the liquid in the liquid phase portion S1 is high, as shown in fig. 5, the membrane member M is displaced toward the gas phase portion S2 side to decrease the capacity of the gas phase portion S2.
Further, in the gas phase portion casing Cb, an opening Cb1 (see fig. 8) is formed at substantially the middle of the bottom surface thereof. The opening Cb1 is formed in the inner peripheral surface (bottom surface) of the gas phase section housing Cb, communicates the flow path of the connection port C3 with the gas phase section S2, and allows the air (gas) in the gas phase section S2 to flow in and out in accordance with the displacement of the membrane member M. However, by connecting one end of the tube K to the connection port C3 and connecting the other end of the tube K to the pressure detection sensor P (pressure detection unit), air (gas) flows in or out from the opening Cb1 in accordance with the displacement of the membrane member M, and the pressure of the gas phase portion S2 is detected by the pressure detection sensor P. The connection port C3 is not limited to the type connected to the pipe K, and may be connected to another mechanism that can transmit the pressure of the gas phase portion S2 to the pressure detection sensor P. Further, as shown in fig. 8, a plurality of ribs Cb2 radially protruding around the opening Cb1 of the recess Cb4 of the gas phase portion S2 are formed around the opening Cb 1.
The inlet port C1 of the present embodiment is configured by a portion (protruding portion) connectable to a liquid channel (blood circuit), and includes, as shown in fig. 4 and 5, a channel portion C1a and a connecting portion C1b, the channel portion C1a allows liquid (blood) to flow in from an inlet Ca1 (see fig. 7) of the liquid phase portion S1, and the connecting portion C1b is connectable to the channel (blood circuit). That is, the flow path portion C1a and the connecting portion C1b are formed so as to communicate with each other in the axial direction inside the protruding portion constituting the inlet port C1, and the liquid in the flow path can be made to flow through the flow path portion C1a by connecting the tube constituting the flow path to the connecting portion C1b, and the liquid can be made to flow into the liquid phase portion S1 from the inlet port Ca 1. The inlet port C1 may have a concave shape connecting tubes constituting a flow path.
The outflow port C2 of the present embodiment is configured by a portion (protruding portion) connectable to a liquid channel (blood circuit), and includes, as shown in the figure, a channel portion C2a and a connection portion C2b, the channel portion C2a allows the liquid (blood) that has flowed into the liquid phase portion S1 to flow out through the outflow port Ca2 (see fig. 7), and the connection portion C2b is connectable to the channel (blood circuit). That is, the channel C2a and the connection portion C2b are formed so as to communicate with each other in the axial direction inside the protruding portion constituting the outflow port C2, and a tube constituting the channel is connected to the connection portion C2b, so that the liquid flowing into the liquid phase portion S1 is made to flow through the channel C2a, and the liquid is made to flow out to the channel (blood circuit) on the downstream side. The outlet port C2 may have a concave shape connecting tubes constituting a flow path.
On the other hand, as shown in fig. 10 and 11, fixing portions Q2 and Q3 are formed at the respective peripheral portions of the liquid phase portion casing Ca (1 st casing portion) and the gas phase portion casing Cb (2 nd casing portion), and a sealing portion Q1 is formed inside the fixing portions Q2 and Q3 (inside the liquid phase portion casing Ca and the gas phase portion casing Cb) in the peripheral portion of the liquid phase portion casing Ca. In the present embodiment, the sealing portion Q1 is formed only on the peripheral edge portion of the liquid phase portion casing Ca, but may be formed only on the inner side of the fixing portions Q2 and Q3 constituting the peripheral edge portion of the gas phase portion casing Cb, or may be formed on the inner side of the fixing portions Q2 and Q3 constituting the peripheral edge portions of the liquid phase portion casing Ca and the gas phase portion casing Cb, respectively.
The fixing portions Q2 and Q3 are formed at the respective peripheral portions of the liquid phase section case Ca and the gas phase section case Cb, and fix the liquid phase section case Ca and the gas phase section case Cb in a matched state, and in the present embodiment, as shown in fig. 10, the liquid phase section case Ca and the gas phase section case Cb are opposed to each other in a matched state, and as shown in fig. 11, the liquid phase section case Ca and the gas phase section case Cb are melted by applying ultrasonic waves while being pressed in directions approaching each other, thereby forming a portion where the liquid phase section case Ca and the gas phase section case Cb are welded to each other. That is, the liquid phase section case Ca and the gas phase section case Cb of the present embodiment are configured to be fixed (welded) while being pressure-bonded by ultrasonic welding, and to form a receiving space (the liquid phase section S1 and the gas phase section S2) therein.
The sealing portion Q1 is a portion formed inside the fixing portions Q2, Q3 in the peripheral portion of the liquid phase portion case Ca or the gas phase portion case Cb and sealing the film member M sandwiched by the sandwiching surfaces M1, M2 along the entire peripheral edge, and in the present embodiment, as shown in fig. 10, the sealing portion Q1 is a portion formed by protruding from the sandwiching surface M1 of the liquid phase portion case Ca toward the sandwiching surface M2 of the gas phase portion case Cb, and as shown in fig. 11, the sealing portion Q1 is a portion sealing the peripheral portion Ma of the film member M by compressing the peripheral portion Ma in the thickness direction while pressing the liquid phase portion case Ca and the gas phase portion case Cb in the direction approaching each other and applying ultrasonic waves to melt and fix the fixing portions Q2, Q3.
Here, if the fixing portions Q2, Q3 are melted, the liquid-phase portion casing Ca and the gas-phase portion casing Cb are fixed, and the sealing of the sealing portion Q1 is performed, the void portion α is formed between the fixing portions Q2, Q3 and the sealing portion Q1. Since the gap α is formed in the process of the liquid phase part enclosure Ca and the gas phase part enclosure Cb approaching each other when the liquid phase part enclosure Ca and the gas phase part enclosure Cb are welded to each other, and is closed by the seal portion Q1, there is a risk that the pressure will rise excessively when the pressure reduction or heating is not performed in the present embodiment.
Next, a manufacturing apparatus of the pressure detector of the medical device according to the present embodiment will be described.
As shown in fig. 12 and 13, the manufacturing apparatus performs welding (fixing) of fixing portions (Q2, Q3) and sealing of a sealing portion Q1 by an ultrasonic welding apparatus 11, a jig 12, a sealing portion R, and a decompression portion 13, and decompresses a sealed space of the sealing portion R when assembling a liquid phase portion casing Ca (1 st casing portion) and a gas phase portion casing Cb (2 nd casing portion).
The jig 12 includes a loading portion 12a, and the loading portion 12a loads the liquid phase portion casing Ca (1 st case portion) and the gas phase portion casing Cb (2 nd case portion) in a state of being fitted while positioning them with the film member M built therein, and the jig 12 is provided at a position below the ultrasonic welding apparatus 11. The ultrasonic welding apparatus 11 includes a horn 11a to which ultrasonic waves can be applied, and the ultrasonic welding apparatus 11 is configured in such a manner that: ultrasonic waves can be applied by pressing 11a against the liquid phase portion casing Ca (1 st casing part) and the gas phase portion casing Cb (2 nd casing part) fixed to the loading part 12a of the jig 12.
The liquid phase portion case Ca and the gas phase portion case Cb that press the horn 11a by the ultrasonic welding apparatus 11 are configured as follows: as shown in fig. 10 and 11, while the fixing portions Q2 and Q3 are pressed against each other by the action of ultrasonic waves, the fixing portions Q2 and Q3 are fixed (welded), and the sealing portion Q1 is compressed by the pressing of the horn 11a, thereby forming a receiving space (the liquid phase portion S1 and the gas phase portion S2) inside.
The sealing portion R is constituted by a container or the like capable of forming a sealed space therein, and as shown in fig. 13, at least the liquid phase portion casing Ca (1 st casing portion) and the gas phase portion casing Cb (2 nd casing portion) fixed by the jig 12 can be sealed. The sealing section R has an opening/closing door or the like, and can open the opening/closing door, and the liquid phase section casing Ca (1 st casing section) and the gas phase section casing Cb (2 nd casing section) are fed into the sealing section R, so that the opening/closing door can be closed, thereby forming a sealed space.
The decompression section 13 is constituted by, for example, an air blower or the like that can discharge the air inside the sealed section R to the outside to perform decompression, and the decompression section 13 is constituted in such a manner that: when the liquid phase part enclosure Ca (1 st enclosure part) and the gas phase part enclosure Cb (2 nd enclosure part) are assembled by fixing the fixing parts Q2 and Q3 and sealing the sealing part Q1, the sealed space of the sealing part R is depressurized. Thus, when the liquid phase section enclosure Ca (1 st enclosure part) and the gas phase section enclosure Cb (2 nd enclosure part) are assembled by fixing the fixing portions Q2 and Q3 and sealing the sealing portion Q1, the inside of the gap α formed between the fixing portions Q2 and Q3 and the sealing portion Q1 can be decompressed.
The heating portion 13 may be formed instead of the decompression portion 13. The heating unit 13 is configured by, for example, a heater that can heat the air in the sealed portion R, and is configured in such a manner that: when the liquid phase part enclosure Ca (1 st enclosure part) and the gas phase part enclosure Cb (2 nd enclosure part) are assembled by fixing the fixing parts Q2 and Q3 and sealing the sealing part Q1, the sealed space of the sealed part R is heated. Thus, when the liquid phase section casing Ca (1 st casing part) and the gas phase section casing Cb (2 nd casing part) are assembled by fixing the fixing parts Q2 and Q3 and sealing the sealing part Q1, the inside of the gap α formed between the fixing parts Q2 and Q3 and the sealing part Q1 can be heated.
Next, a method for manufacturing a pressure detector for a medical device according to an embodiment of the present invention will be described with reference to flowcharts of fig. 14 and 15.
First, a case where the decompression is performed by the decompression section 13 will be described with reference to the flowchart of fig. 14. After the liquid phase section casing Ca is fixed while being positioned with respect to the jig 12 (S1), the membrane member M is provided on the fixed liquid phase section casing Ca (S2). Then, by providing the gas phase portion casing Cb on the membrane element M (S3), the liquid phase portion casing Ca (1 st casing portion) and the gas phase portion casing Cb (2 nd casing portion) are brought into a state of being matched with each other while the membrane element M is built in.
Then, the inside of the sealing portion R is made into a sealed space, and the pressure reducing portion 13 is operated to reduce the pressure in the sealed space (S4). In this depressurized state, the ultrasonic welding apparatus 11 is operated to press the horn 11a against the liquid phase portion casing Ca (1 st casing portion), and the fixing portions Q2 and Q3 are pressed against each other by the action of ultrasonic waves to fix (weld) the fixing portions Q2 and Q3, and the sealing portion Q1 is compressed and sealed by the pressing of the horn 11a, whereby the liquid phase portion casing Ca (1 st casing portion) and the gas phase portion casing Cb (2 nd casing portion) can be joined and assembled (S5).
When the assembly of the liquid phase section casing Ca (1 st casing section) and the gas phase section casing Cb (2 nd casing section) is completed, the closed space inside the closed section R is pressurized (S6), and the assembled product is taken out from the closed section R by opening the door of the closed section R or the like (S7). Although the pressurization in step S6 is preferably performed up to the atmospheric pressure, for example, the pressurization may be performed to a pressure at which the open/close door of the sealing portion R is opened. By the above operation, a series of welding steps are completed, and the inside of the gap α formed between the fixing portions Q2 and Q3 and the sealing portion Q1 is depressurized to the atmospheric pressure in the assembled product. Further, in step S1, a gas phase portion enclosure Cb may be provided, and in step S3, a liquid phase portion enclosure Ca may be provided on the membrane element M, for step S1 and step S2. Also, step S6 may be omitted.
Next, the case of heating by the heating unit 13 will be described with reference to the flowchart of fig. 15. After the liquid phase section casing Ca is fixed while being positioned with respect to the jig (S1), the membrane member M is provided on the fixed liquid phase section casing Ca (S2). Next, by providing the gas phase portion casing Cb on the membrane element M (S3), the liquid phase portion casing Ca (1 st casing portion) and the gas phase portion casing Cb (2 nd casing portion) are brought into a state of being matched with each other while the membrane element M is built in.
Then, the heating unit 13 is operated with the inside of the sealed section R being a sealed space, thereby heating the sealed space (S4). Since the sealed space is in a reduced pressure state by this heating, the horn 11a is pressed against the liquid phase section case Ca (1 st case section) by operating the ultrasonic welding apparatus 11 in the reduced pressure state, the fixing portions Q2 and Q3 are fixed (welded) while being pressed against each other by the action of ultrasonic waves, and the sealing portion Q1 is compressed and sealed by the pressing of the horn 11 a. Thus, the liquid phase part enclosure Ca (1 st enclosure part) and the gas phase part enclosure Cb (2 nd enclosure part) are joined and assembled (S5).
When the assembly of the liquid phase section casing Ca (1 st casing section) and the gas phase section casing Cb (2 nd casing section) is completed, the closed space in the closed section R is cooled (S6), and the assembled product is taken out from the closed section R by opening the door of the closed section R or the like (S7). It is preferable that the cooling in step S6 is performed to room temperature (temperature outside the sealed section R), for example, but the cooling may be performed to a temperature that allows the product to be held by hand when the product is taken out from the sealed section R. Through the above operation, a series of welding steps are ended, and in the assembled product, the inside of the gap α formed between the fixing portions Q2, Q3 and the sealing portion Q1 is in a state of being decompressed with respect to atmospheric pressure. Further, it is also possible to provide the gas phase section enclosure Cb in step S1 and the liquid phase section enclosure Ca on the membrane element M in step S3 with respect to steps S1 and S2. Also, step S6 may be omitted.
However, the pressure detector 10 as a medical instrument manufactured as described above is heated under a condition of a glass transition point or a softening point or less, and then cooled to perform an annealing step of removing internal (residual) stress in the resin. Then, after the annealing step, high-pressure steam sterilization is performed in which sterilization is performed by heating in saturated steam. The high-pressure steam sterilization is performed in an environment in which the boiling point of the high-pressure environment rises and water is retained even at high temperature. Then, the pressure detector 10 as a medical instrument in a wet state by being sterilized by high-pressure steam is dried by being subjected to a drying step.
According to the present embodiment, when the liquid phase section case Ca (1 st case section) and the gas phase section case Cb (2 nd case section) are assembled by fixing (welding) the fixing sections Q2 and Q3 and sealing the sealing section Q1, the inside of the gap α formed between the fixing sections Q2 and Q3 and the sealing section Q1 is depressurized or heated, so that it is possible to improve the quality and reliability by suppressing an excessive increase in pressure inside the gap α formed between the sealing section Q1 and the fixing sections Q2 and Q3 during the annealing step after the assembly of the liquid phase section case Ca (1 st case section) and the gas phase section case Cb (2 nd case section), the high-pressure steam sterilization, and the use in a high-temperature environment.
Further, while the film member M (elastic film) is built in, the liquid phase portion case Ca (1 st case portion) and the gas phase portion case Cb (2 nd case portion) are fixed to the jig 12 in a state of being fitted to each other, fixing (welding) of the fixing portions Q2, Q3 and sealing of the sealing portion Q1 are performed, the liquid phase portion case Ca (1 st case portion) and the gas phase portion case Cb (2 nd case portion) are assembled, and at least the peripheries of the liquid phase portion case Ca (1 st case portion) and the gas phase portion case Cb (2 nd case portion) fixed by the jig 12 are sealed, and the sealed space is decompressed or heated, so that decompression or heating in the gap α can be performed with good efficiency. In particular, according to the present embodiment, since the sealed space is pressurized or cooled after the sealed space is depressurized or heated, the product can be taken out after the sealed space is returned to a stable environment, and the quality can be improved.
In the pressure detector 10, the housing C of the present embodiment is connectable to a liquid flow path, the 1 st receiving space constitutes a liquid phase portion S1 of the fillable flow path, the 2 nd receiving space constitutes a gas phase portion S2 of the fillable gas, the elastic membrane is constituted by a membrane member M that partitions the liquid phase portion and the gas phase portion and is displaceable in accordance with the pressure of the liquid filled in the liquid phase portion, the pressure of the liquid in the flow path is detected by detecting the pressure of the gas phase portion S2, and the quality and reliability of the pressure detector 10 are improved by suppressing an excessive increase in pressure in the gap α formed between the sealing portion Q1 and the fixing portions Q2 and Q3.
The present embodiment has been described above, and the present invention is not limited to this, and for example, the sealing portion R may have a range including the entire ultrasonic welding apparatus 11 and the jig 12 as a sealed space, or may be configured to reduce the pressure and heat the atmosphere of the entire room in which the assembly process of the liquid phase portion enclosure Ca (1 st enclosure portion) and the gas phase portion enclosure Cb (2 nd enclosure portion) is performed. In the present embodiment, the liquid phase part case Ca (1 st case part) and the gas phase part case Cb (2 nd case part) are welded by melting the fixing parts Q2 and Q3 by ultrasonic waves, but the present invention is not limited to ultrasonic welding, and other fixing methods (laser welding, assembly by special press-fitting or screw-fastening, or the like) may be used.
The pressure detector 10 of the present embodiment is connected to the position between the dialyzer 3 and the air trap chamber 5 in the venous blood circuit 2, but may be connected to other positions of the blood circuit (for example, a position between the tip of the arterial blood circuit 1 and the blood pump 4, and a position between the blood pump 4 and the dialyzer 3 in the arterial blood circuit 1). The blood circuit to which the present pressure detector 10 is connected may be of other types, for example, of the type in which the air trap chamber 5 is not connected, but the present pressure detector 10 is connected instead.
The inlet port C1 and the outlet port C2 formed in the liquid phase section enclosure Ca are not limited to 2 as in the above-described embodiment, and may be formed as a single port C4 as shown in fig. 16 and 17 or as 5 ports (C5 to C9) as shown in fig. 18 and 19. In the case of the type shown in fig. 18 and 19, the number of ports formed in the liquid phase section casing Ca is not limited to 5, and may be 4, 5, or 7 or more.
In addition, although the present embodiment is applied to the pressure detector 10 used in the blood circuit for dialysis treatment, the present invention is applicable to other medical instruments (for example, a diaphragm pump, etc.) including a housing formed by fitting a1 st housing part and a2 nd housing part together and having a receiving space therein; an elastic film made of an elastic member, the elastic film being attached to the housing and dividing a1 st receiving space covered by the 1 st housing part and a2 nd receiving space covered by the 2 nd housing part; a fixing portion formed on respective peripheral portions of the 1 st housing portion and the 2 nd housing portion, the fixing portion fixing the 1 st housing portion and the 2 nd housing portion in a fitted state; a holding surface formed on the respective peripheral edge portions of the 1 st housing portion and the 2 nd housing portion, holding the peripheral edge of the elastic film; and a sealing part formed inside the fixing part of the peripheral edge part of each of the 1 st housing part and the 2 nd housing part and sealing the elastic film clamped by the clamping surface at the whole peripheral edge.
For example, when the type shown in fig. 16 and 17 is used as a diaphragm pump, the air pump 20 and the pressure sensor 21 may be connected to the connection port C3, the ports C4 may be connected to the liquid flow paths, the valve Va may be attached to the upstream side of the flow paths, and the valve Vb may be attached to the downstream side of the flow paths, to control the operation. In this case, the air pump 20 is driven to move the membrane member M in the direction laid on the wall surface of the gas phase portion casing Cb (2 nd casing) while opening the valve Va and closing the valve Vb, thereby guiding the liquid into the liquid phase portion casing Ca, and the air pump 20 is driven to move the membrane member M in the direction laid on the wall surface of the liquid phase portion casing Ca (1 st casing) while opening the valve Va and closing the valve Vb, thereby discharging the liquid in the liquid phase portion casing Ca. By repeating such driving of the air pump 20 and operation of the valves Va and Vb, the diaphragm pump can be used. In the figure, the film member M is laid on the wall surface of the liquid phase portion casing Ca (1 st casing part) or the gas phase portion casing Cb (2 nd casing part) and is detected by the pressure sensor 21, but the pressure sensor 21 may not be provided.
For example, when the type shown in fig. 18 and 19 is used as a diaphragm pump, the air pump 20 and the pressure sensor 21 may be connected to the connection port C3, the ports C5 to C9 may be connected to the liquid flow paths, and the valves V1 to V5 may be attached to the flow paths, thereby controlling the operation. In this case, the air pump 20 is driven to move the membrane member M in the direction of the wall surface laid on the gas phase portion casing Cb (2 nd casing portion) while the valve V1 is in the open state and the other valves V2 to V5 are in the closed state, thereby guiding the liquid to the inside of the liquid phase portion casing Ca, and the air pump 20 is driven to move the membrane member M in the direction of the wall surface of the liquid phase portion casing Ca (1 st casing portion) while the valve V1 is in the closed state and the other valves V2 to V5 are in the open state, thereby discharging the liquid inside the liquid phase portion casing Ca. By repeating such driving of the air pump 20 and the operation of the valves V1 to V5, the diaphragm pump can be used. In the figure, the film member M is laid on the wall surface of the liquid phase portion casing Ca (1 st casing part) or the gas phase portion casing Cb (2 nd casing part) and is detected by the pressure sensor 21, but the pressure sensor 21 may not be provided.
Industrial applicability of the invention
The method and apparatus for manufacturing a medical device, which perform decompression and heating of the inside of the gap formed between the fixing portion and the sealing portion when the 1 st housing portion and the 2 nd housing portion are assembled according to the fixing of the fixing portion and the sealing of the sealing portion, can be applied to other modes and uses.
Description of reference numerals:
reference numeral 3 denotes a dialyzer (blood purifier);
reference numeral 7 denotes a receiving portion;
reference numeral 9 denotes a clamping portion;
symbol L1 denotes a dialysate introduction line;
symbol L2 denotes a dialysate discharge line;
symbol L3 denotes a physiological saline supply line;
symbol C denotes a housing;
symbol Ca denotes a liquid phase portion casing (1 st casing portion);
symbol Ca1 denotes an inflow port;
symbol Ca2 denotes an outflow port;
symbol Cb denotes a gas phase section enclosure (2 nd enclosure section);
the symbol Cb1 denotes an opening;
the symbol Cb2 represents a rib;
symbol Cb3 denotes a convex part;
symbol Cb4 denotes a recess;
symbol C1 denotes an inflow port;
symbol C1a denotes a flow path portion;
symbol C1b denotes a connection portion;
symbol C2 denotes an outflow port;
symbol C2a denotes a flow path portion;
symbol C2b denotes a connecting portion;
symbol C3 denotes a connection port;
symbol M denotes a film member (elastic film);
symbol Ma denotes a peripheral edge portion;
symbol P denotes a pressure sensor (pressure detecting unit);
symbol S1 denotes a liquid phase portion (1 st receiving space);
symbol S2 denotes a gas phase portion (2 nd receiving space);
symbol K represents a tube portion;
symbol Q1 denotes a seal portion;
symbols Q2 and Q3 denote anchors;
symbols m1 and m2 denote clamping surfaces;
symbol α represents a void;
the symbol R indicates a sealing portion.
Claims (8)
1. A method of manufacturing a medical device, the medical device comprising:
a housing in which a1 st housing part and a2 nd housing part are formed in an anastomotic manner, with a receiving space inside the housing;
an elastic film attached to the housing, the elastic film defining a1 st receiving space covered by the 1 st housing part and a2 nd receiving space covered by the 2 nd housing part;
a fixing portion formed at a peripheral edge portion of each of the 1 st and 2 nd casing portions, for fixing the 1 st and 2 nd casing portions in a fitted state;
a holding surface formed on the peripheral edge of each of the 1 st and 2 nd casing parts, for holding the peripheral edge of the elastic film;
a sealing portion formed inside the fixing portion in a peripheral edge portion of the 1 st or 2 nd casing portion, the sealing portion sealing the elastic film sandwiched by the sandwiching surfaces at an entire periphery;
the method is characterized in that when the fixing of the fixing part and the sealing of the sealing part are carried out, and the 1 st shell part and the 2 nd shell part are assembled, the inside of a gap formed between the fixing part and the sealing part is decompressed or heated.
2. The method of manufacturing a medical device according to claim 1, wherein the 1 st and 2 nd casing parts are fixed to a jig in a state of fitting while incorporating the elastic film, the fixing of the fixing part and the sealing of the sealing part are performed, the 1 st and 2 nd casing parts are assembled, and at least the peripheries of the 1 st and 2 nd casing parts fixed by the jig are sealed, and the sealed space is depressurized or heated.
3. The method of manufacturing a medical device according to claim 2, wherein the sealed space is pressurized or cooled after the pressure of the sealed space is reduced or heated.
4. The method of manufacturing a medical device according to any one of claims 1 to 3, wherein the medical device is configured by a pressure detector in which the housing is connectable to a flow path of a liquid, the 1 st receiving space is configured as a liquid phase portion in which the liquid in the flow path can be filled, the 2 nd receiving space is configured as a gas phase portion in which a gas can be filled, and the elastic membrane is configured by a membrane member that partitions the liquid phase portion and the gas phase portion and is displaceable in accordance with a pressure of the liquid filled in the liquid phase portion, and the pressure of the liquid in the flow path is detected by detecting a pressure of the gas phase portion.
5. An apparatus for manufacturing a medical device, the medical device comprising:
a housing in which a1 st housing part and a2 nd housing part are formed in an anastomotic manner, with a receiving space inside the housing;
an elastic film attached to the housing, the elastic film defining a1 st receiving space covered by the 1 st housing part and a2 nd receiving space covered by the 2 nd housing part;
a fixing portion formed at a peripheral edge portion of each of the 1 st and 2 nd casing portions, for fixing the 1 st and 2 nd casing portions in a fitted state;
a holding surface formed on the peripheral edge of each of the 1 st and 2 nd casing parts, for holding the peripheral edge of the elastic film;
a sealing portion formed inside the fixing portion in a peripheral edge portion of the 1 st or 2 nd casing portion, the sealing portion sealing the elastic film sandwiched by the sandwiching surfaces at an entire periphery;
the manufacturing apparatus for a medical device is characterized by comprising a decompression unit for decompressing an inside of a gap formed between the fixing unit and the sealing unit when the fixing unit is fixed and the sealing unit is sealed to assemble the 1 st housing unit and the 2 nd housing unit, or a heating unit for heating the inside of the gap.
6. The manufacturing apparatus for a medical device according to claim 5, comprising:
a jig for fixing the 1 st and 2 nd casing parts in a state of being fitted to each other while incorporating the elastic film therein;
a sealing part for sealing the periphery of at least the 1 st housing part and the 2 nd housing part fixed by the clamp;
and the pressure reducing portion or the heating portion reduces or heats the pressure in the sealed space of the sealing portion when the fixing portion is fixed and the sealing portion is sealed to assemble the 1 st housing portion and the 2 nd housing portion.
7. The apparatus for manufacturing a medical device according to claim 6, wherein the closed space is pressurized or cooled after the pressure is reduced or the heat is applied to the closed space.
8. The apparatus according to any one of claims 5 to 7, wherein the medical device is configured by a pressure detector, the housing is connectable to a flow path of a liquid, the 1 st receiving space is configured as a liquid phase portion in which the liquid in the flow path can be filled, the 2 nd receiving space is configured as a gas phase portion in which a gas can be filled, and the elastic membrane is configured by a membrane member that partitions the liquid phase portion and the gas phase portion and is displaceable in accordance with a pressure of the liquid filled in the liquid phase portion, and the pressure of the liquid in the flow path is detected by detecting a pressure of the gas phase portion.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2018119263A JP6694475B2 (en) | 2018-06-22 | 2018-06-22 | Medical device manufacturing method and manufacturing apparatus |
| JP2018-119263 | 2018-06-22 | ||
| PCT/JP2019/024656 WO2019245018A1 (en) | 2018-06-22 | 2019-06-21 | Medical instrument manufacturing method and manufacturing device |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN112292162A true CN112292162A (en) | 2021-01-29 |
| CN112292162B CN112292162B (en) | 2024-04-05 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201980041547.7A Active CN112292162B (en) | 2018-06-22 | 2019-06-21 | Method and apparatus for manufacturing medical device |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US11478885B2 (en) |
| EP (1) | EP3811988A4 (en) |
| JP (1) | JP6694475B2 (en) |
| CN (1) | CN112292162B (en) |
| WO (1) | WO2019245018A1 (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP6637107B2 (en) * | 2018-05-16 | 2020-01-29 | 日機装株式会社 | Pressure detector |
| CN114473495A (en) * | 2022-03-21 | 2022-05-13 | 迈得医疗工业设备股份有限公司 | Discharging device, medical instrument production line and medical instrument production method |
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Also Published As
| Publication number | Publication date |
|---|---|
| EP3811988A1 (en) | 2021-04-28 |
| US20210107100A1 (en) | 2021-04-15 |
| CN112292162B (en) | 2024-04-05 |
| US11478885B2 (en) | 2022-10-25 |
| WO2019245018A1 (en) | 2019-12-26 |
| JP6694475B2 (en) | 2020-05-13 |
| EP3811988A4 (en) | 2022-03-30 |
| JP2019217203A (en) | 2019-12-26 |
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